Degenerative Disc DiseaseNCT04208048
FLXfitTM 15 TLIF Interbody Fusion Device
An observational study of Degenerative Disc Disease, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- FLXfit 15TM device
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 22 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment.
Who may be able to join
- Adult (18-70 y/o)
- Male or Female
- With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- Degenerative disc disease with up to Grade I spondylolisthesis
- Spondylolisthesis
- Failure of at least 6-months conservative treatment
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- BMI < 40
- Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one
- Ability to read, understand, and sign informed consent
Who cannot join
- Infection, local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Pregnancy
- Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
- Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
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- Prior fusion procedure at an adjacent level
- Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
- Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
- Active local infection in or near the operative region
- Active systemic infection and/or disease
- Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
- Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
- Systemic disease that requires the chronic administration of nonsteroidal anti- inflammatory or steroidal drugs
- Suspected or documented allergy or intolerance to implant's materials
- Symptomatic cardiac disease
- Patient unwilling to cooperate with postoperative instructions.
- Any case where the implant components selected for use would be too large or too small to achieve a successful result.
- Patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
- Prior fusion at the level to be treated.
- Back VAS < 4/10
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.
Read the detailed description
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.
- Conditions
- Degenerative Disc Disease
- Being tested
- FLXfit 15TM device
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLXfit 15TM deviceDevice
In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.
| Study group | Role | What they receive |
|---|---|---|
| FLXfit 15 | The FLXfit 15 device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed. Receives: Device: FLXfit 15TM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Did patient achieve fusion?
Measured: through study completion; 2 year
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Measured: 6-week
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Measured: 12- week
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Measured: 6-month
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Measured: 1-year
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Measured: 2-year
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Measured: 6-week
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Measured: 12- week
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Measured: 6-month
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Measured: 1-year
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Measured: 2-year
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Measured: 6-week
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Measured: 12- week
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Measured: 6-month
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Measured: 1-year
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Measured: 2-year
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Measured: 6-week
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Measured: 12-week
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Measured: 6-month
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Measured: 1-year
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Measured: 2-year
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Measured: 6-week
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Measured: 12- week
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Measured: 6-month
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Measured: 1-year
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Oct 2018
- Primary completion1 Mar 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kern Singh, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208048
- Sponsor's protocol ID
- 18073011
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2019
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All study related documents will be shared through a password protected and encrypted program managed by Midwest Orthopedics IT department.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
- ClinicalTrials.gov ID
- NCT04208048
- Acronym / sponsor ID
- 18073011
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.
Detailed description
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLXfit 15 | – | Device: FLXfit 15TM deviceThe FLXfit 15 device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment.
Key inclusion criteria (9 listed)
- Adult (18-70 y/o)
- Male or Female
- With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- Failure of at least 6-months conservative treatment
- BMI < 40
Key exclusion criteria (22 listed)
- Infection, local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Pregnancy
- Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLXfit 15TM deviceIn order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed. | Device | FLXfit 15 |
Primary outcome
Fusion
Time frame: through study completion; 2 year
Did patient achieve fusion?
Visual Analogue Pain Scale: Back
Time frame: 6-week
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Back
Time frame: 12- week
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Back
Time frame: 6-month
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Back
Time frame: 1-year
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Back
Time frame: 2-year
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Leg
Time frame: 6-week
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Leg
Time frame: 12- week
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Leg
Time frame: 6-month
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Leg
Time frame: 1-year
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Leg
Time frame: 2-year
0 to 10 score; higher score means worse pain
Oswestry Disability Index
Time frame: 6-week
0 to 100 score; higher score means greater patient disability
Oswestry Disability Index
Time frame: 12- week
0 to 100 score; higher score means greater patient disability
Oswestry Disability Index
Time frame: 6-month
0 to 100 score; higher score means greater patient disability
Oswestry Disability Index
Time frame: 1-year
0 to 100 score; higher score means greater patient disability
Oswestry Disability Index
Time frame: 2-year
0 to 100 score; higher score means greater patient disability
Short Form-12 Health Survey
Time frame: 6-week
0 to 100 score; higher score means less patient disability
Short Form-12 Health Survey
Time frame: 12-week
0 to 100 score; higher score means less patient disability
Short Form-12 Health Survey
Time frame: 6-month
0 to 100 score; higher score means less patient disability
Short Form-12 Health Survey
Time frame: 1-year
0 to 100 score; higher score means less patient disability
Short Form-12 Health Survey
Time frame: 2-year
0 to 100 score; higher score means less patient disability
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6-week
20 to 80 score; higher score means higher reported self-capability
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 12- week
20 to 80 score; higher score means higher reported self-capability
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6-month
20 to 80 score; higher score means higher reported self-capability
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 1-year
20 to 80 score; higher score means higher reported self-capability
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 2-year
20 to 80 score; higher score means higher reported self-capability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Yes. All study related documents will be shared through a password protected and encrypted program managed by Midwest Orthopedics IT department.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: through study completion; 2 year). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.